X00 标准化、质量管理 标准查询与下载
共找到 210 条与 标准化、质量管理 相关的标准，共 14 页
This European Standard specifies a method for the pressure digestion of foodstuffs intended for the determination of elements. This method has been collaboratively tested in combination with atomic absorption (flame, electrothermal (ET), hydride, cold-vapour) techniques and ICP-MS. Other techniques such as e. g. ICP-OES, voltammetry or atomic fluorescence can be used in combination with this European Standard.
Foodstuffs - Determination of trace elements - Pressure digestion
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- 67.050
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- 2014-10
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This Technical Specification describes a screening procedure for the determination of nitric-acid extractable inorganic arsenic in rice with hydride generation-AAS. The method has been developed and validated for the application of analysis in rice. It has been validated in an interlaboratory study according to ISO 5725 on parboiled rice and brown rice having an inorganic arsenic content of 0,092 mg/kg and 0,191 mg/kg.
Foodstuffs - Determination of hydride-reactive arsenic compounds in rice by atomic absorption spectrometry (Hydride- AAS) following acid extraction
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- 67.060
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- 2014-10
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This Technical Specification describes screening strategies for the detection of genetically modified (GM) DNA in food products by means of PCR methods. The strategies have been established for food matrices, but it can also be applied to other matrices (e. g. feed, seed and samples from field grown plants). Detection of GM DNA is based on PCR methods targeting segments of transgenic DNA sequences (genetic elements, genetic constructs or insertion sites of transgenes). Various combinations of these PCR methods are involved in screening strategies. The methods are applied simultaneously or hierarchically. The general strategy is based on the matrix approach. Examples for the implementation and application of this approach are described. In order to ensure reliable analytical results, the document also provides guidelines for the validation of the performance of qualitative PCR methods applied in screening approaches.
Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Polymerase chain reaction (PCR) based screening strategies
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- 67.050
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- X00
- 发布
- 2014-10
- 实施
(a) Any registrant may apply to modify his/her registration to authorize the handling of additional controlled substances or to change his/her name or address by submitting a written request to the Registration Unit, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in §1321.01 of this chapter for the current mailing address. Additionally, such a request may be submitted on-line at www.DEAdiversion.usdoj.gov.
Food and drugs. Part1301:Registration of manufacturers, distributors, and dispensers of controlled substances. Section1301.51:Modification in registration.
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- 2014-09-09
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- 2014-09-09
(a) Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet.
Food and drugs. Part1301:Registration of manufacturers, distributors, and dispensers of controlled substances. Section1301.75:Physical security controls for practitioners.
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- 2014-09-09
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- 2014-09-09
(a) If acquired by and dispensed under the general supervision of a medical officer described in paragraph (b) of this section, or the master or first officer of the vessel under the circumstances described in paragraph (d) of this section, controlled substances may be held for stocking, be maintained in, and dispensed from medicine chests, first aid packets, or dispensaries:
Food and drugs. Part1301:Registration of manufacturers, distributors, and dispensers of controlled substances. Section1301.25:Registration regarding ocean vessels, aircraft, and other entities.
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- 2014-09-09
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- 2014-09-09
(a) All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Administrator shall use the security requirements set forth in §§1301.72–1301.76 as standards for the physical security controls and operating procedures necessary to prevent diversion. Materials and construction which will provide a structural equivalent to the physical security controls set forth in §§1301.72, 1301.73 and 1301.75 may be used in lieu of the materials and construction described in those sections.
Food and drugs. Part1301:Registration of manufacturers, distributors, and dispensers of controlled substances. Section1301.71:Security requirements generally.
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- 2014-09-09
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- 2014-09-09
(a) Any person who is required to be registered and who is not so registered may apply for registration at any time. No person required to be registered shall engage in any activity for which registration is required until the application for registration is granted and a Certificate of Registration is issued by the Administrator to such person.
Food and drugs. Part1301:Registration of manufacturers, distributors, and dispensers of controlled substances. Section1301.13:Application for registration; time for application; expiration date; registration for independent activities; application forms,
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- 2014-09-09
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- 2014-09-09
(a) Except as provided in paragraph (b) of this section, the registration of any person, and any modifications of that registration, shall terminate, without any further action by the Administration, if and when such person dies, ceases legal existence, discontinues business or professional practice, or surrenders a registration. Any registrant who ceases legal existence or discontinues business or professional practice shall notify the Administrator promptly of such fact. In the case of a surrender, termination shall occur upon receipt by any employee of the Administration of a duly executed DEA form 104 or any signed writing indicating the desire to surrender a registration.
Food and drugs. Part1301:Registration of manufacturers, distributors, and dispensers of controlled substances. Section1301.52:Termination of registration; transfer of registration; distribution upon discontinuance of business.
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- 2014-09-09
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- 2014-09-09
(a) The registrant shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause. For purposes of this subsection, the term ‘‘for cause’’ means a surrender in lieu of, or as a consequence of, any federal or state administrative, civil or criminal action resulting from an investigation of the individual’s handling of controlled substances.
Food and drugs. Part1301:Registration of manufacturers, distributors, and dispensers of controlled substances. Section1301.76:Other security controls for practitioners.
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- X00
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- 2014-09-09
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- 2014-09-09
This European Standard specifies a procedure to determine the migration of substances from factory-made or factory-applied products for use in contact with water intended for human consumption. Materials used to make such products include plastics, rubber and glassy (porcelain/vitreous enamel) materials. This European Standard is applicable to products intended to be used under various conditions for the transport and storage of water intended for human consumption, including raw water used for the production of water intended for human consumption. It covers the extraction by water of substances from the finished products.
Influence of materials on water intended for human consumption - Influence due to migration - Part 1: Test method for factorymade products made from or incorporating organic or glassy (porcelain/vitreous enamel) materials
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- 13.060.20;67.250
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- X00
- 发布
- 2014-07
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(a) Definitions. The following definitions of terms apply to this section: Adverse experience. Any adverse event associated with the use of a biological product in humans, whether or not considered product related, including the following: An adverse event occurring in the course of the use of a biological product in professional practice; an adverse event occurring from overdose of the product whether accidental or intentional; an adverse event occurring from abuse of the product; an adverse event occurring from withdrawal of the product; and any failure of expected pharmacological action.
Food and drugs. Part600:Biological products:general. SubpartD:Reporting of adverse experiences. Section600.80:Postmarketing reporting of adverse experiences.
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- 2014-06-10
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- 2014-06-10
The licensed manufacturer shall submit to the Center for Biologics Evaluation and Research or the Center for Drug Evaluation and Research (see mailing addresses in §600.2), information about the quantity of the product distributed under the biologics license, including the quantity distributed to distributors. The interval between distribution reports shall be 6 months. Upon written notice, FDA may require that the licensed manufacturer submit distribution reports under this section at times other than every 6 months.
Food and drugs. Part600:Biological products:general. SubpartD:Reporting of adverse experiences. Section600.81:Distribution reports.
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- 2014-06-10
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- 2014-06-10
(a) Licensed biological products regulated by the Center for Biologics Evaluation and Research (CBER). Unless otherwise stated in paragraphs (c) or (d) of this section, or as otherwise prescribed by FDA regulation, all submissions to CBER referenced in parts 600 through 680 of this chapter, as applicable, must be sent to: Document Control Center (HFM–99), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Examples of such submissions include: Biologics license applications (BLAs) and their amendments and supplements, adverse experience reports, biological product deviation reports, fatality reports, and other correspondence. Biological products samples must not be sent to this address but must be sent to the address in paragraph (c) of this section.
Food and drugs. Part600:Biological products:general. SubpartA:General provisions. Section600.2:Mailing addresses.
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- 2014-06-10
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- 2014-06-10
(a) A licensed manufacturer may ask the Food and Drug Administration to waive under this section any requirement that applies to the licensed manufacturer under §§600.80 and 600.81. A waiver request under this section is required to be submitted with supporting documentation. The waiver request is required to contain one of the following:
Food and drugs. Part600:Biological products:general. SubpartD:Reporting of adverse experiences. Section600.90:Waivers.
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- X00
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- 2014-06-10
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- 2014-06-10
Guidelines for Halal Catering Enterprises
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- 67.040
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- X00
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- 2014-06-01
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- 2014-07-01
Corporate Guidelines for Halal Flour Products
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- 67.040
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- X00
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- 2014-06-01
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- 2014-07-01
Code of Conduct for Halal Dairy Products
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- 67.040
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- X00
- 发布
- 2014-06-01
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- 2014-07-01
This European Standard specifies a method for the determination of vitamin E in foods by high performance liquid chromatography (HPLC). The determination of vitamin E content is carried out by measurement of α-, β-, γ- and δ-tocopherols. This method has been validated in two interlaboratory studies. The first study was for the analysis of -tocopherol in margarine and milk powder ranging from 9,89 mg/100 g to 24,09 mg/100 g. The second study was for the analysis of α-, β-, γ- and δ-tocopherols in milk powder and of α-, β-, γ- and δ-tocopherols tocopherol in oat powder ranging from 0,057 mg/100 g (β-tocopherol) to 10,2 mg/100 g (α-tocopherol).
Foodstuffs - Determination of vitamin E by high performance liquid chromatography - Measurement of ��-@ ?-@ �� and �� tocopherol
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- 67.050
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- X00
- 发布
- 2014-06
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This European Standard specifies a method for the determination of vitamin A in foodstuffs by high performance liquid chromatography (HPLC). This method has been validated in an interlaboratory study with samples of margarine and milk powder with all-E-retinol levels ranging from 653 µg/100 g to 729 µg/100 g and with 13-Z-retinol levels ranging from 30 µg/100 g to 39 µg/100 g. The determination of vitamin A content is carried out by the measurement of all-E-retinol, 13-Z-retinol and -carotene. This part covers the measurement of all-E-retinol and 13-Z-retinol. The extract obtained after saponification in this method can be used for the determination of -carotene, as described in EN 12823-2:2000, Foodstuffs - Determination of vitamin A by high performance liquid chromatography - Part 2: Measurements of -carotene. In this case, the saponification temperature should preferably not exceed 80 °C in order to prevent isomerisation and oxidation of -carotene.
Foodstuffs - Determination of vitamin A by high performance liquid chromatography - Part 1: Measurement of all-E-retinol and 13-Z-retinol
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- 67.050
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- X00
- 发布
- 2014-05
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